This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.

Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke With Qi Deficiency and Blood Stasis Syndrome: a Multicenter, Randomized,Double-blind，Placebo- and Active-controlled Adaptive Study

Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:

change in the Lower Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Aphasia Quotient（AQ) score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90 [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Change in the Upper Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Change in the total Fugl-Meyer motor score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

Change in the syndrome score of Qi Deficiency and Blood Stasis [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ] [ Designated as safety issue: No ]

the incidence of New-onset cardiovascular events [ Time Frame: during the 20-weeks ] [ Designated as safety issue: Yes ]

Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night;the routine recovery training.

intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal（placebo was taken only after lunch, and Qizhitongluo Capsule was taken after breakfast and supper)for 12 weeks.

Space-occupying lesions, CT or MRI revealed midline structure shift; CT revealed that massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery.

Suspected addicted into alcohol or drug abuse; with severe complications that would make the condition more complicated assessed by the investigator.

Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent.

Patient who is participating in other trials or has been participated in other trials in recent 3 months.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01762163